The effects of novel chocolate on postprandial blood glucose level in healthy adults

Acronym

The effects of dietary novel chocolate on postprandial blood glucose

Scientific Title

The effects of novel chocolate on postprandial blood glucose level in healthy adults

Scientific Title:Acronym

The effects of dietary novel chocolate on postprandial blood glucose

Region

Japan

Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Objectives

Narrative objectives1

We randomly allocated twelve subjects to administer any of the novel chocolate, the control chocolate, and the sugar to investigate the postprandial blood glucose level, followed by a washout period. These subjects were then crossed over and received the alternative chocolate.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Blood glucose level, the blood glucose areas under the curve (AUC), the maximum blood glucose level(Cmax) , and time to reach Cmax(Tmax)

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Pseudo-randomization

Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Single dose administration of 65 g of the novel chocolate in intervention period

Interventions/Control_2

Single dose administration of 65 g of the control chocolate in control period

Interventions/Control_3

Single dose administration of 19.2 g of sugars in sugars period

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

20

years-old

<=

Age-upper limit

29

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) All subjects voluntarily signed the informed consent after detailed description and understanding of this study
2) Those who belong to a particular university.
3) Subjects with fasting blood glucose level within normal range between 70 mg/dL and 110 mg/dL using the first blood test
4) Subjects with systolic blood pressure under 140 mmHg and diastolic blood pressure under 90 mm Hg
5) Subjects with BMI above 18.5 kg/ m2-under 30 kg/ m2
6) Females who have a regular menstrual cycle, which is 25 to 38 days, and at the first test, who are from 14 days after the start of their menstruation to the next menstruation.
7) Non-smokers

Key exclusion criteria

1) Those who administer ''Food for Specified Health Use'', ''Foods with Function Claims'' or medicine to have effects on blood glucose metabolism.
2) Patients with diseases undergoing treatments or with medical history of severe diseases.
3) Patients who have severe diseases: diabetes, liver disease, kidney disease, heart disease (or persons who have history of these diseases).
4) Those who may suffer from allergy by administering milk, soybean, or cacao mass (chocolate).
5) Subjects who are in pregnancy, lactation.
6) Those who were included other clinical trials within one month before giving written informed consent, or during this study.
7) Any other medical and/or health reasons unfavorable to participation in this study, as judged by the principal investigator or examination doctor.

Target sample size

12

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name

Professor Toshihiro Miura

Organization

Suzuka University of Medical Science

Division name

Faculty of Health Science

Zip code

Address

1001-1, Kishioka, Suzuka-city, Mie, 510-0293

TEL

059-383-8991

Email

miura@suzuka-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name

Midori Natsume

Organization

Meiji Co., Ltd.

Division name

Group2, Food Science & Technology Research Laboratories, R&D Division

Zip code

Address

1-29-1 Nanakuni, Hachiouji, Tokyo 192-0919

TEL

042-632-5850

Homepage URL

Email

midori.natsume@meiji.com

Sponsor

Institute

Suzuka University of Medical Science

Institute

Department

Funding Source

Organization

Meiji Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Institutions

鈴鹿医療科学大学（三重県）

Other administrative information

Date of disclosure of the study information

2018

Year

12

Month

24

Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

Number of participants that the trial has enrolled

11

Results

1) Analysis of all subjects revealed no significant difference between the control and test diets.
2) The test diet showed significant decrease in incremental area under the curve when compared with sucrose only while control diet did not change.
3) Compared to sucrose only, the chocolate with or without fructooligosaccharides significantly decreased blood glucose and Cmax.